AG-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

มีจำหน่ายจาก:

ANGITA PHARMA INC.

รหัส ATC:

N06AX23

INN (ชื่อสากล):

DESVENLAFAXINE

ปริมาณ:

50MG

แบบฟอร์มเภสัชกรรม:

TABLET (EXTENDED-RELEASE)

องค์ประกอบ:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

100

ประเภทใบสั่งยา:

Prescription

สรุปสินค้า:

Active ingredient group (AIG) number: 0152509001; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2022-03-04

สรุปลักษณะสินค้า

PRODUCT MONOGRAPH
Pr
AG-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 and 100 mg desvenlafaxine (as desvenlafaxine succinate monohydrate)
Antidepressant
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3
SUBMISSION CONTROL NO.: 260512
_AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph _
_Page 1 of 57_
Date of Revision:
February
28, 2022
_AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph_
_Page 2 of 57_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION.
.............................................................. 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................3
CONTRAINDICATIONS
......................................................................................................
4
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE REACTIONS
....................................................................................................
13
DRUG INTERACTIONS
....................................................................................................24
DOSAGE AND ADMINISTRATION
................................................................................28
OVERDOSAGE
...................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...............................................................33
STORAGE AND STABILITY
............................................................................................37
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................37
PART II: SCIENTIFIC INFORMATION
..................................................................................